drugs

Olanzapine Teva

What is Olanzapine Teva?

Olanzapine Teva is a medicine containing the active substance olanzapine, and is available as tablets (white and round: 2.5, 5, 7.5 and 10 mg; blue and oval: 15 mg; pink and oval: 20 mg and orodispersible tablets round (yellow: 5 and 10; orange: 15; green 20 mg) Orodispersible tablets are tablets that dissolve in the mouth.

Olanzapine Teva is a "generic medicine". or a drug similar to "reference drugs", already authorized in the European Union (EU) called Zyprexa and Zyprexa Velotab. For more information on generic medicines, see the questions and answers by clicking here.

What is Olanzapine Teva used for?

Olanzapine Teva is indicated for the treatment of adults with schizophrenia. Schizophrenia is a mental illness characterized by a series of symptoms, including thought and speech disorders, hallucinations (seeing or hearing things that do not exist), suspiciousness and delusions. Olanzapine Teva is also effective in maintaining clinical improvement in patients who responded positively to initial treatment.

The drug is also used for the treatment of moderate to severe manic episodes in adults (particularly euphoric mood). It can also be used to prevent the recurrence of manic episodes (reappearance of symptoms) in adults with bipolar disorder (a disease

mentality characterized by the alternation of manic and depressive phases) in patients who responded to initial treatment.

The medicine can only be obtained with a prescription.

How is Olanzapine Teva used?

The recommended initial dosage of Olanzapine Teva depends on the disease to be treated: for schizophrenia and the prevention of manic episodes it is 10 mg a day, for the treatment of manic episodes it is 15 mg a day, unless it is used in combination with other drugs, in which case the starting dose may be 10 mg a day. The dosage can be adapted to the patient's response and therapy tolerance. The usual dose varies between 5 and 20 mg a day. Orodispersible tablets, which can be administered as an alternative to traditional tablets, must be placed on the tongue, where they are rapidly dispersed in the saliva, or they can be dissolved in the water before being taken. It may be necessary to reduce the starting dose by 5 mg per day in patients over 65 and in subjects with liver or kidney problems.

How does Olanzapine Teva work?

The active substance in Olanzapine Teva, olanzapine, is an antipsychotic drug, known as an "atypical" antipsychotic, as it differs from the old antipsychotic drugs available since the 1950s. Although its exact mechanism of action is not known, it is linked to some receptors on the surface of nerve cells in the brain. In this way the signals transmitted between the brain cells are interrupted through neurotransmitters, ie the chemical substances that allow nerve cells to communicate with each other. It is believed that the beneficial effect of olanzapine is due to its ability to block receptors for neurotransmitters 5- hydroxytryptamine (also called serotonin) and dopamine. Because these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine contributes to the normalization of brain activity, reducing the symptoms of these diseases.

What studies have been carried out on Olanzapine Teva?

Since Olanzapine Teva is a generic medicine, the studies have limited itself to demonstrating that the drug is bioequivalent to the reference medicine (ie that the medicines produce the same levels of the active substance in the body).

What are the benefits and risks of Olanzapine Teva?

Because Olanzapine Teva is a generic medicine and is bioequivalent to the reference drugs, yes

assumes that the benefits and risks of the drug are the same.

Why has Olanzapine Teva been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Olanzapine Teva has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab. It is therefore the opinion of the CHMP that, as in the case of Zyprexa and Zyprexa Velotab, the benefits outweigh the risks identified. The committee recommended the granting of a marketing authorization for Olanzapine Teva.

More information on Olanzapine Teva

On 12 December 2007, the European Commission granted Teva Pharma BV a marketing authorization for Olanzapine Teva valid throughout the European Union.

The full EPAR version for Olanzapine Teva can be found here.

The full EPAR versions for the reference medicines can be consulted on the EMEA website.

Last update of this summary: 09-2008